MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ
Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo
Stock Exchange (Code Number: 4875), today announced results from
its subgroup analysis of the SPRINT-MS Phase 2b trial of MN-166
(ibudilast) in progressive multiple sclerosis (progressive MS).
This subgroup analysis was conducted based on recent feedback
MediciNova received from the FDA that relapsing secondary
progressive MS (i.e. secondary progressive MS with relapse) is
different from non-relapsing secondary progressive MS (i.e.
secondary progressive MS without relapse) as non-relapsing
secondary progressive MS is the only type of secondary progressive
MS without available therapy. The purpose of the subgroup
analysis was to provide information about which types of
progressive MS subjects responded best to MN-166 (ibudilast)
treatment in terms of the clinically significant endpoint of the
risk of confirmed disability progression compared to placebo, as
measured by EDSS. Confirmed disability progression was a
secondary endpoint in this Phase 2b trial but would be considered a
primary endpoint in Phase 3. Unlike the magnetic resonance
imaging (MRI) endpoint of whole brain atrophy, which is not a
clinical endpoint, confirmed disability progression is the most
important clinical endpoint and is the basis for FDA approval of
progressive MS drugs. As shown in the following table, the
trends for reduction in the risk of confirmed disability
progression were highest for the subgroup of subjects with
Secondary Progressive MS without Relapse, in which MN-166
(ibudilast) demonstrated a 46% risk reduction compared to placebo
as indicated by the hazard ratio of 0.538.
Risk of Confirmed Disability Progression:Cox
Hazard Ratios of the Two Treatments by SubgroupIntent-To-Treat
(ITT) Analysis Set
|
Number of Subjects |
|
|
Subgroup |
MN-166 |
Placebo |
Hazard Ratio* |
Risk Reduction |
Primary Progressive MS |
68 |
66 |
0.707 |
29% |
Secondary Progressive MS with Relapse |
9 |
6 |
1.153 |
-15% |
Secondary Progressive MS
without Relapse |
52 |
54 |
0.538 |
46% |
*MN-166 vs. Placebo |
|
|
|
|
There is a large market opportunity for treating Secondary
Progressive MS without Relapse as the vast majority of secondary
progressive MS patients do not have relapses. For example,
only 12% of secondary progressive MS patients had a relapse in the
SPRINT-MS Phase 2b trial of MN-166 (ibudilast) in progressive MS
which included 96 weeks of treatment. In addition to the
large market opportunity, there is still no drug approved for
long-term treatment of secondary progressive MS patients without
relapses.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc. commented, “We are excited with the results of our
subgroup analysis. Although two drugs have recently received
FDA approval for relapsing secondary progressive MS, there remains
a very large unmet medical need for secondary progressive MS
patients without relapses as there is still no drug approved for
long-term treatment of these patients. Based on our extensive
analysis of the SPRINT-MS data including this subgroup analysis, we
are finalizing the optimal trial design for what we believe will be
a very successful Phase 3 program and we plan to submit this trial
design to the FDA shortly. With a convenient oral
administration, a very favorable safety and tolerability profile,
and the potential for better efficacy than other drugs for
progressive MS, we believe ibudilast could become the
best-in-disease drug.”
About the Progressive MS Trial
The Phase 2b Secondary and Primary Progressive Ibudilast
NeuroNEXT trial in Multiple Sclerosis (SPRINT-MS) included 28
enrolling clinical sites across the U.S. and was designed to
evaluate the safety, tolerability and activity of MN-166
(ibudilast) administered orally twice daily to subjects with
primary progressive or secondary progressive multiple sclerosis
(PPMS or SPMS, respectively). 255 qualifying subjects were
randomly assigned 1:1 to inactive control (placebo) or MN-166
(ibudilast) administered at a dose of up to 100 mg/day (50 mg twice
daily). The progressive MS subjects were either untreated with
long-term disease modifying therapy (DMT) or continued on either
glatiramer acetate (GA) or interferon beta (IFNβ-1a or IFNβ-1b)
treatment. Hence, randomization was controlled (stratified) by two
factors: therapy status (IFN/GA vs. no DMT) and disease status
(PPMS vs. SPMS). The primary objectives of the study were to 1)
evaluate the activity of ibudilast (MN-166) versus placebo at 96
weeks as measured by quantitative magnetic resonance imaging (MRI)
analysis for whole brain atrophy using brain parenchymal fraction
(BPF), and 2) evaluate the safety and tolerability of ibudilast
(MN-166) versus placebo in subjects with PPMS or SPMS. Additional
measures included disability, imaging analyses of brain and retinal
tissue integrity, cortical atrophy, cognitive impairment,
quality-of-life and neuropathic pain. Exploratory objectives
included pharmacokinetic and biomarker analyses.
About the Cooperative Effort
The collaborating entities included NeuroNEXT, the Cleveland
Clinic, the National MS Society and MediciNova. NINDS's Network for
Excellence in Neuroscience Clinical Trials, or NeuroNEXT, was
created to conduct studies of treatments for neurological diseases
through partnerships with academia, private foundations and
industry. NeuroNEXT sites include many of the leading medical
centers in the U.S. (www.neuronext.org). The goals of NeuroNEXT
include testing of promising neurological therapies in Phase 2
clinical trials, optimizing drug development time and cost
components through an established clinical trials infrastructure,
and the coordination of public/private sector efforts by leveraging
NINDS’s existing relationships with academic investigators and
patient advocacy groups. A clinical coordinating center for
NeuroNEXT is led by Dr. Merit Cudkowicz and is based at
Massachusetts General Hospital and the data coordinating center is
led by Dr. Chris Coffey at the University of Iowa. Principal
Investigator Dr. Robert Fox and colleagues at the Cleveland Clinic
collaborated with co-investigators at academic medical centers in
the NeuroNEXT network. The National MS Society provided patient
advocate input, trial enrollment awareness, and additional funding.
MediciNova holds the trial IND with the FDA’s Division of Neurology
Products and provided scientific and analytical support, as well as
drug and placebo supply.
About Progressive Multiple Sclerosis
According to the National MS Society, MS affects approximately
2.3 million people worldwide. Approximately 85% of MS patients are
initially diagnosed with relapsing remitting MS (RRMS). Most RRMS
patients will eventually transition into SPMS in which there are
fewer or no relapses but gradual worsening of neurologic function.
Approximately 15% of MS patients are diagnosed with PPMS at onset
and exhibit gradually increasing disability in walking, vision,
mental acuity, and other bodily functions without experiencing
relapses or remissions. Current therapies for MS affect the
inflammatory response, but provide limited benefit for the
neurodegeneration seen in progressive MS. There is a significant
unmet medical need for agents that may provide neuroprotection in
progressive MS.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a first-in-class, orally bioavailable,
small molecule macrophage migration inhibitory factor (MIF)
inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that
suppresses pro-inflammatory cytokines and promotes neurotrophic
factors. It attenuates activated glial cells, which play a major
role in certain neurological conditions. MN-166 (ibudilast)'s
anti-neuroinflammatory and neuroprotective actions have been
demonstrated in preclinical and clinical studies, which provide the
rationale for treatment of progressive multiple sclerosis (MS) and
other neurological diseases such as amyotrophic lateral sclerosis
(ALS), glioblastoma (GBM), and substance abuse/addiction.
MediciNova is developing MN-166 for progressive MS and other
neurological conditions such as ALS, glioblastoma, substance
abuse/addiction, and chemotherapy-induced neuropathy. MediciNova
has a portfolio of patents which covers the use of MN-166
(ibudilast) to treat various diseases including progressive MS,
ALS, and drug addiction.
About MediciNova
MediciNova, Inc. is a publicly-traded biopharmaceutical company
founded upon developing novel, small-molecule therapeutics for the
treatment of diseases with unmet medical needs with a primary
commercial focus on the U.S. market. MediciNova's current strategy
is to focus on MN-166 (ibudilast) for neurological disorders such
as progressive multiple sclerosis (MS), amyotrophic lateral
sclerosis (ALS), substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence) and glioblastoma
(GBM), and MN-001 (tipelukast) for fibrotic diseases such as
nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary
fibrosis (IPF). MediciNova’s pipeline also includes MN-221
(bedoradrine) and MN-029 (denibulin). For more information on
MediciNova, Inc., please visit www.medicinova.com.
Statements in this press release that are not historical in
nature constitute forward-looking statements within the meaning of
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements include,
without limitation, statements regarding the future development and
efficacy of MN-166, MN-001, MN-221, and MN-029. These
forward-looking statements may be preceded by, followed by or
otherwise include the words "believes," "expects," "anticipates,"
"intends," "estimates," "projects," "can," "could," "may," "will,"
"would," “considering,” “planning” or similar expressions. These
forward-looking statements involve a number of risks and
uncertainties that may cause actual results or events to differ
materially from those expressed or implied by such forward-looking
statements. Factors that may cause actual results or events to
differ materially from those expressed or implied by these
forward-looking statements include, but are not limited to, risks
of obtaining future partner or grant funding for development of
MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient
capital when needed to fund MediciNova's operations and
contribution to clinical development, risks and uncertainties
inherent in clinical trials, including the potential cost, expected
timing and risks associated with clinical trials designed to meet
FDA guidance and the viability of further development considering
these factors, product development and commercialization risks, the
uncertainty of whether the results of clinical trials will be
predictive of results in later stages of product development, the
risk of delays or failure to obtain or maintain regulatory
approval, risks associated with the reliance on third parties to
sponsor and fund clinical trials, risks regarding intellectual
property rights in product candidates and the ability to defend and
enforce such intellectual property rights, the risk of failure of
the third parties upon whom MediciNova relies to conduct its
clinical trials and manufacture its product candidates to perform
as expected, the risk of increased cost and delays due to delays in
the commencement, enrollment, completion or analysis of clinical
trials or significant issues regarding the adequacy of clinical
trial designs or the execution of clinical trials, and the timing
of expected filings with the regulatory authorities, MediciNova's
collaborations with third parties, the availability of funds to
complete product development plans and MediciNova's ability to
obtain third party funding for programs and raise sufficient
capital when needed, and the other risks and uncertainties
described in MediciNova's filings with the Securities and Exchange
Commission, including its annual report on Form 10-K for the year
ended December 31, 2018 and its subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Undue reliance should not be
placed on these forward-looking statements, which speak only as of
the date hereof. MediciNova disclaims any intent or obligation to
revise or update these forward-looking statements.
INVESTOR CONTACT:Geoff O'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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